Events

Safety Alert for Ibis Comfort wheelchair

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Nordic Capital Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-07-05
  • Event Date Posted
    2013-07-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130705.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: handicare ibis comfort wheelchair the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning a number of ibis comfort wheelchairs, delivered between 29 january and 12 april 2013, manufactured by handicare b.V. the affected serial numbers are: rix01437, rix01439, rix01440, rix01442, rix01665, rix01682, rix01732, rix01805, rix01828, rix01847, rix01850, rix01869, rix01882, rix01931, rix01963, rix01992, rix01999, rix02068, rix02077, rix02098, rix02174, rix02236, rxps00847, rxps00873, rxps00882. handicare has discovered a potential quality issue with the tilt adjustment on a limited number of ibis comfort wheelchairs. in extreme situations, a component used in the tilt mechanism may break, which could cause the seat unit to tip backwards. according to handicare, no injuries have been reported. handicare has decided to replace all components from the affected batch as a precautionary measure. users are requested to order a replacement set and exchange the upper hinge blocks (article no.: 02010.6182) used in the tilt mechanism on all affected wheelchairs they have. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con295475 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 july 2013.

Device

Ibis Comfort wheelchair
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Handicare Ibis Comfort wheelchair
  • Manufacturer
    Nordic Capital Limited

Manufacturer

Nordic Capital Limited
  • Source
    DH